For type 2 diabetes mellitus. NDA 219122, held by Azurity. Sitagliptin Hydrochloride.
As of Nov 14, 2026, NDA 219122 (Brynovin), held by Azurity, was first approved by FDA on Jan 16, 2025, with 0 approved supplements and 1 published complete response letter.
BRYNOVIN is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use BRYNOVIN is not recommended in patients with type 1 diabetes. BRYNOVIN has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using BRYNOVIN..
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 16, 2025 | Original applicationNew dosage form · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Nov 4, 2024 | SitagliptinFacility Inspections | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| BrynovinEQ 25MG BASE/ML · solution;oral | Sitagliptin Hydrochloride | DiscontinuedReference drug |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
